Clinical Trial

"Dapagliflozin vs Dapagliflozin-Finerenone for Albuminuria in CKD With Type 2 Diabetes"

Not Yet Recruiting Phase 3
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Summary
Chronic kidney disease (CKD) in patients with type 2 diabetes mellitus (T2DM) is a major cause of morbidity, commonly associated with persistent albuminuria and progressive renal decline. Reducing albuminuria is a key therapeutic goal to slow disease progression. Sodium-glucose cotransporter-2 inhibitors like dapagliflozin and non-steroidal mineralocorticoid receptor antagonists such as finerenone have independently shown significant renoprotective effects. Their combined use may provide additive benefits. This open-label randomized controlled trial will be conducted in the Department of Nephrology, Chittagong Medical College Hospital, Bangladesh, including 88 patients with CKD and T2DM. Participants will be randomized into two groups: one receiving dapagliflozin 10 mg plus finerenone 10 mg daily, and the other receiving dapagliflozin 10 mg alone for eight weeks. The primary outcome will be the change in urinary albumin-to-creatinine ratio (UACR). Secondary outcomes include serum creatinine, estimated glomerular filtration rate (eGFR), and serum potassium. Safety and adverse events will also be monitored. Data will be analyzed using SPSS version 27. This study aims to assess whether combination therapy is more effective than dapagliflozin alone in reducing albuminuria and may help guide treatment strategies in diabetic CKD.
Trial Details
NCT Number NCT07598864
Lead Sponsor Chittagong Medical College
Conditions Diabetic Nephropathy
Enrollment 88 participants
Start Date 2026-05-01
Primary Completion 2027-05-01 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-20